White Paper
Enhanced Sterility Assurance In Stopper Processing
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•White Paper: Enhanced Sterility Assurance In Stopper Processing
By Sartorius Stedim Biotech
Stoppers for pharmaceutical primary packaging must preserve the safety and efficacy of injectable drugs. Thus, before their intended use, these stoppers undergo multiple processing steps, including washing, rinsing, siliconization, steam sterilization and drying. Each step is critical to ensure the physical and mechanical properties of the stoppers by reducing particles, adding the appropriate silicon volume, sterilizing and avoiding re-contamination due to residual moisture.
An additional critical step after the stopper processing is maintenance of closure integrity until filling in aseptic conditions.
This paper discusses the validation of the transfer of stoppers from a stopper processing system, using a new aseptic transfer technology. It demonstrates that this technology maintains the sterility of the stoppers after their transfer into sterile single-use bags in an ISO Class 7 or 8 environment.
A number of industry trends are changing the drug development landscape. The increase in the production of biologicals, a market which is forecasted to reach $12.6B in 2010, along with live vaccines, large molecules and protein based injectable drugs, require advanced aseptic processing. Such growth has driven the need for new and improved filling technologies. Consequently, both EU & US regulatory authorities recommend using isolators for aseptic processing to decrease the risk of microbiological contamination due to human interaction.
Click Here To Download:•White Paper: Enhanced Sterility Assurance In Stopper Processing
